Subject: Inqovi 4002-A SGM P2023
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INQOVI
(decitabine and cedazuridine)
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Policy:
I. INDICATIONS
The indications below including FDA-approved indications and
compendial uses are considered a covered benefit provided that
all the approval criteria are met and the member has no
exclusions to the prescribed therapy.
A. FDA-Approved Indications
Inqovi is indicated for treatment of adult patients with
myelodysplastic syndromes (MDS), including previously
treated and untreated, de novo and secondary MDS with
the following French-American-British subtypes (refractory
anemia, refractory anemia with ringed sideroblasts,
refractory anemia with excess blasts, and chronic
myelomonocytic leukemia [CMML]) and intermediate-1,
intermediate-2, and high-risk International Prognostic
Scoring System groups.
B. Compendial Use
Myelodysplastic syndrome/myeloproliferative neoplasm
(MDS/MPN) overlap neoplasm
All other indications are considered experimental/investigational
and not medically necessary.
II. CRITERIA FOR INITIAL APPROVAL
A. Myelodysplastic syndromes (MDS)
Authorization of 12 months may be granted for the treatment
of myelodysplastic syndromes (MDS).
B. Myelodysplastic syndrome/myeloproliferative
neoplasm (MDS/MPN) overlap neoplasms
Authorization of 12 months may be granted for the treatment of
MDS/MPN overlap neoplasms (i.e., chronic myelomonocytic
leukemia (CMML), BCR-ABL negative atypical chronic myeloid
leukemia (aCML), MDS/MPN with neutrophilia, unclassifiable
MDS/MPN, or MDS/MPN with ring sideroblasts and
thrombocytosis).
III. CONTINUATION OF THERAPY
Authorization of 12 months may be granted for continued
treatment in members requesting reauthorization for an
indication listed in Section II when there is no evidence of
unacceptable toxicity or disease progression while on the current
regimen.
Place of Service:
Outpatient
The above policy is based on the following references:
- Inqovi [package insert]. Princeton, NJ: Taiho Oncology, Inc; March 2022.
- The NCCN Drugs & Biologics Compendium® © 2023 National Comprehensive Cancer Network, Inc. Available at http://www.nccn.org. Accessed January 7, 2023.
Copyright Aetna Inc. All rights reserved. Pharmacy Clinical Policy Bulletins are developed by Aetna to assist in administering plan benefits and constitute neither offers of coverage nor medical advice. This Clinical Policy Bulletin contains only a partial, general description of plan or program benefits and does not constitute a contract. Aetna does not provide health care services and, therefore, cannot guarantee any results or outcomes. Participating providers are independent contractors in private practice and are neither employees nor agents of Aetna or its affiliates. Treating providers are solely responsible for medical advice and treatment of members. This Clinical Policy Bulletin may be updated and therefore is subject to change.
June 18, 2023
